Trials: PIONEER-AF (n=2124)
  1. Rivaroxaban 15 mg daily + P2Y12 inhibitor (mainly clopidogrel)
  2. Rivaroxaban 2.5 mg twice daily + DAPT (ASA + P2Y12 inhibitor, mainly clopidogrel). Step down to rivaroxaban 15mg daily + P2Y12 inhibitor
  3. Traditional triple therapy: ASA + clopidogrel + warfarin
Primary endpoint

Clinically significant bleeding (composite of TIMI major, minor or requiring medical attention) at 12 months

  1. Rivaroxaban 5 mg daily+clopidogrel: 16.8%
  2. Rivaroxaban 2.5 mg BID + DAPT: 18.0%
  3. Traditional triple therapy (ASA+clopidogrel+warfarin): 26.7% (p<0.001 versus both groups 1 and 2)
Comments
  • Prevalence of AF: 100%
  • Clopidogrel used as the P2Y12 inhibitor in >93% of patients
  • Duration of triple therapy for groups and 3 were not randomized (1, 6 or 12 months)
  • Most of the reduction in bleeding was in bleeding requiring medical attention with no difference in TIMI major or minor bleeding
  • Not powered to detect differences in efficacy
  • Use of PPI: <40%